RecruitingPhase 2NCT04858269

First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients

Phase II Study of First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients

Sponsor

Wake Forest University Health Sciences

Enrollment

32 participants

Start Date

May 27, 2021

Study Type

INTERVENTIONAL

Conditions

Head & Neck Cancer Metastatic Squamous Cell Carcinoma Oropharynx Squamous Cell Carcinoma Oral Cavity Squamous Cell Carcinoma Larynx Squamous Cell Carcinoma Hypopharynx Squamous Cell Carcinoma

Summary

The purpose of this research is to see what effects the treatment regimen chemotherapy (carboplatin and paclitaxel) plus immunotherapy (pembrolizumab), has on patients who have been diagnosed with head/neck squamous cell carcinoma and are unable to take the drug 5-fluorouracil

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new weekly chemotherapy plus immunotherapy regimen for people with head and neck cancer (of the mouth, throat, or voice box) that has come back or spread and cannot be cured by local treatment. **You may be eligible if...** - You have squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, or a neck node with unknown primary - Your cancer has come back or spread and cannot be treated with curative surgery or radiation - Your cancer has been confirmed by pathology **You may NOT be eligible if...** - You are able to receive infusional 5-FU chemotherapy or it is feasible for you - Your cancer type is cutaneous (skin-origin) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle

DRUGCarboplatin

Carboplatin dosed for area under the curve (AUC) 1.5 IV on days 1, 8, 15 of each 3-week cycle

DRUGPaclitaxel

Paclitaxel 45 mg/m2 on days 1, 8, 15 of 3-week cycle.

Locations(1)

Wake Forest Baptist Health Sciences

Winston-Salem, North Carolina, United States

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NCT04858269

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